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Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer (Study P03480AM5)(COMPLETED)

2014-08-27 03:54:26 | BioPortfolio

Summary

Primary Objective(s):

- To compare the activity (progression-free survival [PFS]) of anastrozole in combination with lonafarnib to that of anastrozole in combination with placebo in subjects with hormone-sensitive ADVANCED breast cancer.

Secondary Objective(s):

- To determine the effects of anastrozole in combination with lonafarnib on objective response, duration of response, overall survival, and safety in subjects with advanced breast cancer. To assess the exposure and pharmacokinetics of lonafarnib and anastrozole in the subject population.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

Lonafarnib plus Anastrozole, Placebo plus Anastrozole

Status

Completed

Source

Schering-Plough

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:26-0400

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